Microbiologist
Location: Ahmedabad, Gujarat, India
Company: Baxter
Job Requisition ID: JR - 189559
Employment Type: Full-Time
Experience Required: 2–5 Years
Job Overview
Baxter is seeking a qualified Microbiologist to join its Quality team in Ahmedabad. This role is critical in ensuring microbiological compliance, sterility assurance, and adherence to current Good Manufacturing Practices (cGMP) within pharmaceutical manufacturing operations.
The selected candidate will be responsible for performing microbiological testing, sterility testing, environmental monitoring, method validation, and supporting quality management systems (QMS) to ensure patient safety and regulatory compliance. This opportunity is ideal for professionals with hands-on microbiology laboratory experience in a GMP-regulated pharmaceutical environment.
Key Responsibilities
Microbiological Testing & Analysis
Perform periodic microbiological tests as per approved Standard Operating Procedures (SOPs).
Conduct Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) reagents.
Perform sterility testing and collect samples for sterility analysis.
Test raw materials (RM), packing materials (PM), and pre-sterile products for bio-burden.
Conduct microbiological analysis of stability samples as per daily work plans.
Perform gram staining of colonies and identify microorganisms using BBL Crystal or equivalent systems.
Enumerate and report plates/tubes and supervise proper discarding procedures.
Water & Environmental Monitoring
Test water samples for physicochemical, biochemical, and chemical parameters.
Ensure documentation of water testing activities in compliance with cGMP requirements.
Qualify prepared media through growth promotion testing.
Qualify personnel for cleanroom entry and microbiological compliance.
Laboratory Documentation & Compliance
Maintain contemporaneous documentation of all laboratory activities in line with data integrity (ALCOA+) principles.
Maintain and reconcile stock records of LAL reagents, media, standards, and house isolates.
Prepare, maintain, and update culture records for routine use.
Ensure compliance with cGMP and internal quality standards.
Validation & Quality System Support
Perform method validation activities as per approved protocols.
Support equipment and process validation/qualification activities.
Coordinate with the Technical department regarding machine-related abnormalities impacting microbiological quality.
Support OOS investigations, QMS documentation, CAPA, and related quality elements for timely closure.
Operational & Cross-Functional Coordination
Monitor laboratory inventory and provide monthly procurement requirements.
Escalate abnormalities in microbiological analysis to Executive or Department Head.
Perform additional assigned responsibilities as per organizational requirements.
Educational Qualification
Bachelor’s or Master’s degree in Microbiology, Biotechnology, Life Sciences, or related discipline.
Required Skills and Experience
2–5 years of experience in pharmaceutical microbiology laboratory under cGMP environment.
Hands-on experience in sterility testing, endotoxin testing, bio-burden testing, and environmental monitoring.
Strong knowledge of microbiological method validation and growth promotion testing.
Familiarity with data integrity practices and regulatory compliance requirements.
Good documentation practices and strong analytical skills.
Core Competencies
Detail-oriented with strong quality focus
Critical thinker with problem-solving ability
Strong documentation and compliance mindset
Effective cross-functional communication
Ability to work in GMP-regulated cleanroom environments
Why Join Baxter?
Baxter’s Quality function plays a vital role in safeguarding patient safety and product integrity. Employees benefit from professional development programs, health and well-being initiatives, paid time off, volunteer opportunities, and a collaborative work culture focused on excellence and compliance.
Equal Employment Opportunity
Baxter is an equal opportunity employer and evaluates qualified applicants without regard to legally protected characteristics. Reasonable accommodations are available for individuals with disabilities during the recruitment process.
This Microbiologist role is an excellent opportunity for professionals seeking growth in pharmaceutical microbiology, sterility assurance, regulatory compliance, and GMP laboratory operations within a global healthcare organization.
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